A randomized withdrawal, active- and placebo-controlled, double-blind, multi-center Phase III trial assessing safety and efficacy of oral CG5503 PR* in subjects with moderate to severe chronic malignant tumor-related pain*PR means Prolonged Release and is the recommended nomenclature for use in EU. ER means Extended Release and is the recommended nomenclature for use in USA. PR is synonymous with ER and is interchangeable in the protocol.

• Conditions: The treatment of chronic tumor-related pain.; MedDRA version: 9.1Level: LLTClassification code 10033371Term: Pain; MedDRA version: 9.1Level: PTClassification code 10033371Term: Pain

• Registration Number: EUCTR2007-001985-34-LV
• Lead Sponsor: & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 573

Inclusion Criteria

Subjects must have signed an informed consent document
indicating that they understand the purpose of and procedures
required for the trial and are willing to participate in the trial.
• Male and non-pregnant, non-lactating female subjects. Sexually
active women must be post menopausal, surgically sterile, or
practicing an effective method of birth control (e.g. prescription oral
contraceptives, contraceptive injections, intrauterine device, double
barrier method, contraceptive patch, male partner sterilization)
before entry and throughout the trial. Female subjects must have a
negative pregnancy test at Screening.
• At least 18 years of age.
• Chronic malignant tumor-related pain.
• Subjects who are opioid-naïve or pretreated with an equianalgesic
dose range equivalent of up to 160 mg oral morphine per day and are dissatisfied with prior treatment.
• Subjects with a mean pain intensity = 5 points (11-point NRS) on
the day of randomization at the start of Titration phase.
• Expected course of the disease and the pain that will permit
compliance with the trial protocol over the entire trial period.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

History of alcohol and/or drug abuse in the investigator’s judgment,
based on patient history and physical examination.
• The subject has a clinically significant disease other than cancer
which in the investigator's opinion may affect efficacy or safety
assessments e.g. significant unstable cardiac, vascular, pulmonary,
gastrointestinal, endocrine, neurological, psychiatric (resulting in
disorientation, memory impairment or inability to report accurately)
or metabolic disturbances.
• Any scheduled surgery during the trial.
• Any painful procedure during the trial that may, in the opinion of
the Investigator, affect the efficacy or safety assessments.
• Employees of the investigator or trial center, with direct
involvement in the proposed trial or other trials under the direction
of that investigator or trial center, as well as family members of the
employees or the investigator.
• Known to or suspected of not being able to comply with the
protocol and the use of CG5503 or morphine.
• Have received an experimental drug or used an experimental
medical device within 30 days before the planned start of treatment.
• Participation in another trial concurrently.
• Subjects who have participated in previous trials of CG5503.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified